Ampoule with actuatable cover automatically readying ampoule for injection



. 3,368,55 7 LLY Feb. 13, 1968 V. HASSING ET Al- AMPOULE wma AOTUATABLECOVER AuTOMATlOA READYINO AMPOULE FOR INJECTION Filed May 24, 1965United States Patent O M 3,368,557 AMPOULE WITH ACTUATABLE COVER AU-TOMATICALLY READYING AMPOULE FOR INJECTION Vagn Hassing, Farum, andEjnar Kristian Jeppesen,

Bagsvaerd, Denmark, assignors to Novo Terapeutisk Laboratorium A/S,Copenhagen, Denmark, a Danish joint-stock company Filed May 24, 1965,Ser. No. 458,009 Claims priority, application Denmark, May 28, 1964,2,674/ 64 5 Claims. (Cl. 12S-221) ABSTRACT 0F THE DISCLOSURE Aninjection ampoule with a two-part cover which is actuatable axially onthe ampoule for automatically ejecting an outer part of the coverexposing the injection needle and placing it in communication with theampoule contents thereby readying the ampoule for injection `by a singlemovement of the cover.

The present invention relates to an injection ampoule, closed at one endwith a fixed piercable closure and provided with a tubular neck, onwhich a cannula provided with a socket is axially displaceably arranged,and into which a perforation tube projects. The tube is disposed incommunication with the cannula, the end of the perforation tube adjacentthe pierceable closure is point-ed.

Such known injection ampoules are sold with contents, for example asterile remedy or medicament, are normally discarded after use. Thecannula or needle is normally, by means of its socket, arranged on thetubular neck immediately before the ampoule is to be used. As thecannula socket is pushed into the tubular neck, it will actuate theprojecting end of the perforation tube so that its opposite pointed endprojects through a pierceable closure. whereby the hollow injectioncannula is placed in communication with the interior of the ampoule. Thesterile medicament may now, during an injection, be forced out throughthe cannula, either by compression of the arnpoule, if the latterconsists of a compressible material, or if the ampoule has the form of arigid cylinder, by expelling the remedy of the ampoule by means of apiston.

However, injection ampoules are known, in which the perforation tubeforms a part of the cannula. The cannula has the form of a specialdouble cannula, which between its pointed ends is provided with anoutside annular bead. In this known injection ampoule the cannula issurrounded by a protective cap made in one piece and provided with athreaded skirt screwed on one end of the ampoule. The part of theprotective cap surrounding the cannula is connected with the threadedskirt over a weakened, annular wall portion, and on the threaded skirtare provided external threads. A threaded sleeve is screwed having aange directed axially inwardly towards the weakened wall portion. Whenthis type of known ampoule is to be used, the sleeve is screwed inwardlyin a direction towards the ampoule. The axial ilange of the threadedsleeve will abut against the protective cap adjacent the weakened wallportion of the latter. If one continues to screw the threaded sleeveinwardly, the protective cap will be broken along the weakened wallportion, whereby the outer part of the cap falls off so that the cannulawill be uncovered. If the threaded sleeve is screwed further inwardly,the axial flange on the threaded sleeve will press the bead on thedouble cannula inwardly .towards the ampoule, and the inner end of thecannula will penetrate into the interior of the ampoule, and finally thecannula will be fixed by the clamping of the bead of the can- 3,368,557Patented Feb. 13, 1958 nula between the axial ange of the threadedsleeve and the adjacent end of the ampoule. The injection ampoule isthen ready for use.

The structure last described has, in comparison with the rst-mentionedstructure, the advantage that it is not necessary to touch the sterilecannula, as the ampoule may be made ready for use by turning thethreaded sleeve. Thus there is no risk that the cannula is contaminatedwhen the injection ampoule is made ready for use. However, thelast-mentioned of the known injection ampoules has the disadvantage thatit is rather expensive because it requires the use of a special cannula.Furthermore, the necessary screwing of the threaded sleeve for makingthe ampoule ready for use is rather time-consuming.

yThe object of the invention is to provide an injection ampoule havingnot only all the advantages of the known injection ampoules, but alsohaving such a construction that it can be made ready for use by a singleaxial displacement movement.

This may, according to the invention, be obtained by having the cannulaand its socket surrounded by a twopiece protective cap slidable inrelation to the ampoule. The outer part of the protective cap,surrounding the cannula, has inner parts which, by axial displacement ofthe protective cap, may be brought to abut against the cannula socket.The two cap parts are secured to each other by locking means adapted tobe released by an axial force on the two cap parts in a direction awayfrom each other. The injection ampoule according to the invention isvery simply made read for use fby a displacement of the inner part ofthe protective cap in a direction towards the ampoule. During thismovement the outer part of the pro tective cap will abut against thecannula socket, whereby the socket will be moved in a direction towardsthe ampoule. By this movement of the cannula socket the pointed end ofthe perforation tube will pass through a pierceable closure and into theinterior of the ampoule. The movement of the cannula socket will finallylbe stopped by the cannula socket abutting against the ampoule oragainst the parts secured to the ampoule. When the cannula socket cannotbe moved further inwardly, a continued application of force on the innercap part in direction towards the ampoule will result in the outer cappart being actuated by such a great axial force in a direction away fromthe inner cap part that the connection between the two cap parts isreleased. The outer cap part will then fall oit and uncover the cannulaplacing the injection ampoule in readiness for use. The functional stepsdescribed in detail above follow in practice very quickly after eachother, and the ampoule can, as mentioned, be made ready for use in amoment by an inward displacement of the inner cap part. With theinjection arnpoule according to the invention it is furthermorepossible, contrary to what is the case with known ampoules, to use acheap standard cannula, if desired, which may be used again aftersterilization, e.g. in connection with a common syringe.

If the threaded sleeve in known injection ampoules were replaced by anaxially displaceable sleeve, no injection ampoule would be obtainedwhich in practice comes up to the ampoule according to the invention.When casting the protective cap for the known structures it is necessaryto work with such wide tolerances that the thickness of the weakenedwall portion will vary substantially. In several cases the wall portionwill be so thick that it would be very diicult to break it -by a manualaxial displacement of the sleeve provided with the axial ilange. Inseveral other cases the weakened wall portion will be so thin that itbreaks unintentionally or may even have holes, which is. of course,unfortunate since the cannula in this case will become unsterile.

It is important that the cannula during an injection is maintainedfirmly secured to the tubular neck, and that the perforation tube isactually passed through the piercable closure. So the inner cap partmay, according to the invention, be provided with an inside shoulder,which by inward displacement of the cap part may be brought to abutagainst a corresponding, outside shoulder on the cannula socket. `If thelocking means is of such a type that it is released by a pressure, lessthan that necessary to pass the perforation tube -through the piercableclosure, the inner shoulder of the inner cap part will be pressedtowards the outside shoulder of the cannula socket, after the lockingmeans has been released, so that the pressure necessary for theperforation and the securing of the cannula socket will be transferredto the cannula socket. Furthermore during the injection the cannulasocket may be held pressed firmly against the :ampoule or parts securedthereto.

As previously mentioned the ampoule as such may be formed of acompressible material. However, it is preferred to give it the form of arigid cylinder, the mouth of which is surrounded by a cylindrical parthaving a tubular neck. In the last-mentioned case the inner cap partmay, according to the invention, have a strapped, cylindrical form, andthe end of the inner cap part facing the ampoule may have such an innerdiameter that it may surround and be guided axially on the ampoule,whereas the adjacent part of the cap part may have such an innerdiameter that it is guided on, abuts against the cylindrical part of thetubular neck. This provides good axial control of the protective cap inremoving it and simultaneously a good seal between the cylindrical partof the neck and the adjacent part of the protective cap, therebypreventing contamination of the sterile cannula surrounded by theprotective cap during storage of the injection ampoule. The seal mayeasily be obtained between the protective cap and the tubular neck,because the neck is normally manufactured of metal and may thus bemanufactured with rather narrow tolerances. On the other hand, it willbe more diicult to obtain tightness or a seal between the protective capand the ampoule as such, since the ampoule is normally made of glassresulting in rather wide tolerances.

In certain cases it is not desired to use a protective cap, the innerpart of which covers part of the ampoule, since part of a label securedthereto may thus be covered. According to the invention the tubular neckmay have a substantially cylindrical surface, while the inner cap partmay have inner, radially directed guiding ribs, the inner edges of whichabut against the outer surface of the neck, and the end of the inner cappart facing the ampoule may have such an inner diameter that it isguided on and tightly surrounds the mouth of the ampoule. The tight fitof the cap part around the mouth of the ampoule ensures that the sterilecannula is not contaminated before use, and the guiding ribs ensure asufficiently good guiding of the inner cap part during axialdisplacement of the latter in preparing the ampoule for use.

The locking means between the two cap parts may in principle be of anytype, provided it is released by a suitable axial force between theparts. However, according to the invention the locking means mayadvantageously have the form of a snap fastening connection. Such aconnection may -be made by forming the ends of the cap parts adjacent toeach other in a simple way.

The snap fastening connection may, according to the invention, consistof an annular bead arranged on the end of the outer cap part, projectingaxially from a radially extending flange and fitting by a lightinterference fit into the adjacent end opening of the inner cap part.Thus the desired holding together of the cap parts is obtained, and atthe same time the radial flange abutting against the adjacent end of theinner part of the protective cap results in stability of the connectionagainst sidewards forces acting on the outer cap part. Accordingly anunintentional uncovering of the cannula is prevented.

The snap fastening connection may, according to the invention, insteadbe formed by an outwardly pointed neck formed on the outer end of theinner cap part and having a conical outer surface provided with anannular groove, and by a socket formed on the inner end of the outer cappart, and having a conical inner surface which may be brought tosurround and abut against the outer surface of the neck. The socket hasan inwardly projecting bead fitting into the annular groove. In thisembodiment a particularly good stability against incidental outsideactuations of the outer cap part is obtained because of the conicalabutting surface between the two parts of the protective cap.

If the conicity of the conical surfaces is comparatively small, one mayrisk that when the bead of the outer cap part has been pressed out ofthe corresponding groove in the neck of the inner cap part, it will abutresiliently against the conical outer surface of the neck outside thegroove, and consequently the outer cap part will tend to hang on to theinner cap part, after the snap fastener has been released. This may,according to the invention, be prevented by providing another 4annulargroove between the outer end of the neck and the annular groove andimmediately adjacent the last-mentioned groove.

In the following description the invention will be further explainedwith reference to the drawings, in which FIG. 1 is a fragmentarylongitudinal section view of an embodiment of the injection ampouleaccording to the invention,

FIG. 2 is afragmentary section view, on an enlarged scale, of thelocking means between the parts of the protective cap,

FIG. 3 is a fragmentary longitudinal section View of another embodimentof the locking means, and

FIG. 4 is a longitudinal section view of another embodiment of theinjection ampoule according to the invention,

In FIG. 1 of the drawings there is shown 1an ampoule 10 of glass, rigidplastic or a similar material. The ampoule has a neck 11 provided with acollar or flange 12, on which a punctuable or piercable disc 13 of e.g.rubber or soft plastic is arranged. The disc 13 is held firmly on thecollar 12 by means of a tubular neck 14, a lower edge 15 of which isbent inwardly under the collar 12, while .an inner shoulder 16 bearsagainst the piercable disc 13. The outer free end of the neck 14 has aslightly conical outer surface.

Within the neck 14 there is -arranged a perforation tube 17 pointed atits inner end facing the disc 13, while the other end of saidperforation tube projects beyond the neck 14. A cannula socket 18provided with a cannula 19 rests on the perforation tube 17. The cannulasocket 18 has an inner conical surface 20 corresponding to the conicalsurface of the neck 14 and surrounding the upper end of the neck.

The cannula 19, the cannula socket 18, the neck 14, and the upper end ofthe ampoule 10 are surrounded by a two-piece tubular protective cap orcover 21, an outer part 22 of which is secured to an inner part 23 bymeans of a snap fastening connection or releasable friction connections24. The snap fastening connection consists, as more clearly -appearsfrom FIG. 2, as an annular bead 25 arranged on the end of the outer end22 of the protective cap. The beads project in an axial direction from aradially extending flange 26 and lits by a light interference fit, intoan adjacent end opening 27 of Athe inner cap part 23. The end opening 27has a configuration corresponding to the bead 25.

The inner cap part 23 is provided with steps 28 and 29 so that the spacebetween the protective cap 21 and the parts which the cap surrounds isas small as possible. Furthermore, the cap part 23 is provided with acircumferential grip flange 30. A part 31 of the cap part 23 lyingbetween the steps 29 and the grip flange 30 has an inner diameterexactly corresponding to the outer diameter of a cylindrical part 32 ofthe tubular neck I14 surrounding the neck or flange 12 of the ampoule10. The protective cap is guided, on the tubular neck part 32 and alsocontamination of the sterilized cannula 19 is prevented as laterexplained. The protective cap is further guided in relation to theampoule by means of a cylindrical part 33 guidingly surrounding part ofthe cylindrical ampoule 10.

The injection ampoule is provided with a piston, not shown, arrangedwithin the ampoule 10, said piston being connected with a piston rodprojecting from the ampoule. The ampoule 10 contains some remedy oriluid to be administered to a patient by injection.

The injection ampoule comes from the factory in the state shown inFIG. 1. When an injection is to be made, the protective cap 21 is, bymeans of the gripange 30, displaced axially in a direction towards theampoule 10. Since the outer end of the cannula socket 18 bears againstthe bead 25 on the cap part 22, the cannula socket and the cannula willtake part in the axial movement of the protective cap. It is the samewith the perforation tube 17, the outer end of which bears against thecannula socket 18. So the irst thing that happens during the axialdisplacement of the protective cap 21 is that the pointed end of theperforation tube 17 is pressed through the piercable disc 13. During thecontinued axial movement of the protective cap toward the ampoule theconical surface of the cap will be wedged on the outer conical surfaceof the neck 14. The cannula socket 18 can then no longer be moved, and acontinued inward actuation of the inner cap part 23 will thereforeresult in breaking of the snap fastening connection 24 between the twocap parts 22 and 23 so that the bead 25, by means of the cannula socket18, is pushed out of the end opening 27. The outer cap part 22 now fallsoff the cannula 19 so that said cannula is uncovered, and the injectionampoule is then ready for use.

Any releasable locking means between the two cap parts 22 and 23 may beused if only these locking means can be released by exposing the outercap part to a suitable outward press-ure by the cannula socket. Thepressure necessary to release the locking means should preferably begreater than that necessary to perforate the disc 13 by means of theperforation tube 17 and to press the cannula socket 18 sumciently ontothe neck 14, so that the cannula is only uncovered when the injectionampoule is quite ready for use, i.e., when the disc 13 has beenperforated, and the cannula socket 18 has been pressed on the neck 14.However, it is also po-ssible to use locking means more easilyreleasable, so that the cannula 19 is at once uncovered when thedisplacement of the protective cap is, started. By continuing thedisplacement of the cap an inner shoulder 34- formed by the step 28 willbear against an annular shoulder 35 on the cannula socket 18, wherebythe socket is moved inwardly towards the ampoule, so that theperforation of the disc 13 and the securing of the cannula socket on theneck 14 will take place in the indicated order.

In FIG- 3 another snap fastening connection 36j is shown, which may beused in connection with the embodiment of the injection ampouleaccording to the invention, shown in FIG. 1, instead of the snapfastening connection 24. The snap fastening connection 36 consists of atruncated cone-formed neck 38 formed on the inner cap part 23 and of asocket 39 tting therewith and formed on the lower end of the outer cappart 22. The socket has an inner truncated cone-formed surface which maybe brought to surround and abut against the outer surface of the neck3-8. The outer surface of the neck 38 is provided with two annulargrooves 40` and 41 adjacent each other, and the socket 39' has an innerbead 42 at its inner end, said bead engaging the groove 41, when the capparts 22 and 23 are secured t-o each other by means of the snapfastening connection 36. In this position the free end of the neck 38furthermore abuts against an inner shoulder 43 in the socket 39. Thuscomparatively large abutting surfaces between the inner and the outercap part are provided when the parts are secured to each other by meansof the snap fastening connection 36, so that there is no risk that thesnap fastening connction is unintentionally released by a small outeractuation of the outer cap part 22.

The snap fastening connection, shown in FIG. 3, may as previouslydescribed in connection with the snap fastening connection 24, bereleased by displacing the inner cap part 23 inwa-rdly towards theampoule 10, the cannula socket 18 then at some time prevents furtherinward movement of the outer cap part 22. The bead 42 is then forced outof the groove 41, and the presenceof the groove 40 prevents the cap part22 from hanging on to the outer conical surface of the neck 38.

The injection ampoule shown in FIG. 4 has a double cannula 44 having asubstantially cylindrical cannula socket 45. An inner pointed end 46 ofthe double cannula 44 serves as a perforation tube, and the cannulasocket 45 is arranged axially displaceably within the neck 14 of theampoule 10. The neck is substantially cylindrical. The injection ampouleshown in FIG. 4 is provided with a protective cap 47 consisting of anouter and an inner part 48 and 49, respectively, which are kept togetherby means of a snap fastening connection substantially corresponding tothat shown in FIG. 3 apart from the outer groove 40 being somewhat moreattened in FIG. 4 than in FIG. 3. Inner, radial ribs 50 are formedinside the outer cap part 48. Lower edges of the ribs abut the outer endsurface of the cannula socket 45. The inner cap part 49 has at its outerend an inwardly directed edge 51, and the cannula socket 4S is providedwith a corresponding outwardly extending flange 52. Also the inner cappart 49 is provided wit-h inner, radial ribs 53, the inner edges ofwhich touch the outer surface of the neck 14, which here is cylindrical,and the ribs 53 thus serve to axially guide the cap part. The cap part49 is furthermore axially guided by its inner part having an innerdiameter corresponding to the outer diameter of the cylindrical part 32surrounding the collar 12 of the ampoule 10.

When the injection ampoule shown in FIG. 4 is to be used, the corrugatedouter side of the inner cap part 49 is clasped, and the cap part ismoved axially inwardly. When only the snap fastening connection betweenthe two parts of the protective cap 47 is sufficiently strong, the outercap part 48 will also be brought axially inwards. As the ribs 50 in thecap part 48 abut the cannula socket 45, the socket will also be movedaxially inwardly and the inner end of thedou-ble cannula 44 will bepassed through the piercable disc 13 and into the interior of theampoule 10. When the inward movement of the cannula socket 45 isstopped, either as a result of the abutment of the ange 52 on thecannula socket against the outer edge of the neck 14, or of the abutmentof the inner end of the cannula socket against the closing disc 13, afurther axially inward movement of the inner cap part 49 will cause therelease of the snap fastening connection between the two cap parts sothat the outer cap part 48 falls off, whereby the outer part of thecannula 44 is uncovered. The injection ampoule is now made ready foruse. If the snap fastening connection between the cap parts for somereason should be released too early, so that the outer cap part 48 fallsolf before the cannula end 46 has perforated the closing disc 13, theinwardly directed edge 51 of the inner cap part 49 will abut against theflange 52 on the cannula socket 45 so that the injection ampoule maynevertheless be made ready for use by a continued inward movement of theinner cap part 49.

The injection ampoule according to the invention may as explained abovebe made ready for use by a single action, and the risk of contaminationof the sterile cannula before an injection is prevented. After use theinjection ampoule will normally be disposed of, since the ampoule may bemade so inexpensively that a succeeding sterilization will beunprofitable. However, it should be noted that with some embodiments ofthe injection ampoule according to the invention it is possible to usestandard cannulae and, therefore, the standard cannulae may, if desired,be sterilized and used again, e.g. in connection with a common syringe.

What we claim is:

1. An injection ampoule comprising, a container portion for amedicament, means defining an outlet opening on said ampoule containerportion, a puncturable sealing member covering said outlet, an extensionneck member on said container portion having a bore in communicationwith said puncturable sealing member, a two-part tubular cap on saidampoule actuatable axially relative to said ampoule container portion ina direction toward said container portion, a cannula in said cap mountedwithin said cap and movable axially therewith, a socket mounting saidcannula in said cap movable axially with said cap and cooperative withsaid neck member mounting said cannula on said neck member extending insaid neck member bore in communication with the interior of saidcontainer portion when said cap is actuated axially toward saidcontainer portion, means on said cannula puncturing said sealing memberwhen said cap is actuated and constructed to provide communicationbetween an injection end of the cannula and the interior of saidcontainer portion, said cap comprising an outer end portion having aclosed end and releasable frictionally axially from a remainder of saidcap for exposing said cannula from an injection, means on said outer endportion of said cap defining a releasable friction connection with saidremainder of said cap, means on said socket limiting the axial travelthereof relative to said extension neck member and allowing sufficientaxial travel for said sealing member to be punctured and said cannulaplaced in communication with the interior of said container portion, andmeans on said cap effective to release said outer end portion of saidcap from the remainder of said cap when said cap is actuated axially onsaid ampoule toward said container portion and the travel of said socketceases, whereby when said cap is manually actuated axially toward saidcontainer portion said sealing member is automatically punctured andsaid cannula is placed in communication with the interior of saidcontainer portion and the outer end portion of said cap is ejectedaxially exposing the cannula in position and readiness for an injection.

2. An injection ampoule according to claim 1, in which said extensionneck member has a tapered outer configuration, said means on said socketlimiting axial travel thereof relative to said extension neck membercomprising means defining a tapered bore in said socket into which saidextension neck member is received and said socket wedged and stoppingaxial travel of said outer portion of said cap and said cannula whensaid cap is actuated, said socket having an outer end engaged by saidmeans on said cap rendered effective to release the outer end portion ofsaid cap when said cap is actuated axially.

3. An injection ampoule according to claim 1, in which remainder of saidcap comprises a tubular portion guided axially on said containerportion.

4. An injection ampoule according to claim 1, in which said socket isdisposed in said bore of said extension neck member, said means on saidcannula puncturing said sealing member comprises an inner end portion ofsaid cannula, said means on said socket limiting axial travel thereofrelative to said extension neck member comprises a radial projectionaxially spaced from said extension neck member and engaging the outerend of said extension neck member when said cap is actuated toward saidcontainer portion.

5. An injection ampoule comprising, a container portion for amedicament, means defining an outlet opening on said container portion,a puncturable sealing member covering said outlet, an extension neckmember on said container portion having a bore in communication withsaid sealing member, a two-piece protective cap on said ampoulefrictionally mounted for axial travel on said ampoule container portionin a direction toward said container portion, a cannula mountedinternally of said tubular cap spaced axially from said sealing member,means releasably connecting the cannula to the cap for limited axialtravel therewith when said cap is actuated toward said containerportion, said cap comprising an outer end portion having a closed endand an inner portion releasably connected together, means on saidcannula for travel through said bore puncturing said sealing member andplacing an injection end of said cannula in communication with theinterior of said container portion, said means releasably connectingsaid cannula to said cap comprising socket means for said cannulacooperating with said cap to limit axial travel to said cannula whensaid cap is actuated toward said container portion and allowingsufficient axial travel relative to said neck member to allow puncturingof said sealing member and said cannula to be placed in communicationwith the interior of said container portion, and said socket meanshaving means cooperative with said extension neck member renderedeffective to cause release of the outer end of said cap from the innerportion thereof and eject said outer end axially to clear said cannulaso that said cannula is exposed and in readiness for an injection whenaxial travel of said socket means ceases.

References Cited RICHARD A. GAUDET, Prima/'y Examiner.

D. L. BAKER, Assistant Examiner.

